Senior Clinical Data Manager (Remote), Duke Cancer Institute

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Senior Clinical Data Manager (Remote), Duke Cancer Institute

Oncology Clinical Research Unit [CRU]

MiSTIC Clinical Research Program

 

Position Description, 

Occupational Summary

This position will be responsible for Advarra EDC Platform building for Duke-led Investigator Initiated Trials (iiTs) including Multisite iiTs (miiTs), validation of new Advarra EDC releases and updates and be the Data Quality and Accuracy Oversight Manager for all iiTs, including miiTs, monitoring incoming data from Duke and external sites for quality, timeliness and occasionally accuracy.

This position will be responsible for creating training and SOPs specific to good clinical data practices and data quality management for the entire CRU.

This position will be responsible for overall study and site management for miiTs that fall under Multisite Trials Service Center’s (MiSTiC) portfolio.

 

Work Preformed

 

Data – 45% Effort

• Provide support for various tools used for analysis and data management. Selects and implements data capture methods appropriate for the research program. 
• Serves as an expert in designing ECRFs and EDCs to collect data according to protocols and research program processes. Manage and clean data in preparation for analysis under supervision.
• Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke.
• Develops and implements protocols for research programs that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke.
• Works with the CRU or departmental leadership to ensure that data is shared according to best practices and guidelines. For multiple study teams, provide guidance on the use of data standards. Provides training and oversight into EDC creation using appropriate data standards.
• For studies reporting to the FDA, coordinate the CDISC and CDASH data standard setup and the CDISC dataset transformation tasks.
• Under supervision, performs de-identification on allowable data to Safe Harbor standards.
• Serves as an expert resource to multiple study teams/research program regarding mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke.
• Recognizes when 21 CFR Part 11 applies to a project and follows policy related to testing and validation. Provides oversight and training to multiple study teams on validation and testing for EDCs.
• Work with biostats and PIs after managing data clean-up and database locks to develop data visualizations (e.g., tables, graphs) for manuscripts and lay summaries.
• Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.
• Under direct supervision from Biostatistician and PI may perform analyses on a variety of data formats and create data analysis plans.
• Seeks out, integrates, and applies new technical knowledge towards innovation and performance i